Download Vetropolycin HC 3.5g - US - Insert - Proof 12

®
VETROPOLYCIN HC
bacitracin-neomycin-polymyxin
with hydrocortisone acetate 1%
veterinary ophthalmic ointment
STERILE - ANTIBACTERIAL
NADA # 065-015. Approved by FDA.
DESCRIPTION: Each gram contains Bacitracin Zinc 400 units. Neomycin
Sulfate 5 mg (equivalent to 3.5 mg of Neomycin base), Polymyxin B Sulfate
10,000 units, Hydrocortisone Acetate 10 mg (1%), in a base of White Petrolatum
and Mineral Oil.
ACTIONS: The overlapping spectra of these three antibiotics provide effective
bactericidal action against most commonly occurring gram-positive and
gram-negative bacteria associated with infections of the eyes. The range of
bactericidal activity encompasses many bacteria which are, or have become,
resistant to other antibiotics, notably Pseudomonas and Staphylococcus.
In susceptible organisms, resistance rarely develops, even on repeated or
prolonged usage. Hydrocortisone acetate exerts a marked anti-inflammatory
action at the tissue level and effectively suppresses inflammation in many
disorders of the anterior segment of the eye. Local application to the eye often
gives rapid relief of pain and photophobia, particularly in lesions of the cornea.
The combined anti-inflammatory and antimicrobial activity of Vetropolycin® HC
(bacitracin-neomycin-polymyxin-hydrocortisone acetate 1%) veterinary
ophthalmic ointment permits effective management of many disorders of the
anterior segment of the eye in which combined activity is needed.
INDICATIONS: It may be used in acute or chronic conjunctivitis, when caused
by organisms susceptible to the antibiotics contained in this ointment.
Laboratory tests should be conducted including in vitro culturing and
susceptibility tests on samples collected prior to treatment.
CONTRAINDICATIONS: Ophthalmic preparations containing corticosteroids
are contraindicated in the treatment of those deep, ulcerative lesions of the
cornea where the inner layer (endothelium) is involved, in fungal infections
and in the presence of viral infections.
WARNINGS: All topical ophthalmic preparations containing corticosteroids
with or without an antimicrobial agent, are contraindicated in the initial
treatment of corneal ulcers. They should not be used until the infection
is under control and corneal regeneration is well under way.
Serious hypersensitivity (anaphylactic) reactions have been
reported in cats within 4 hours of application of antibiotic
ophthalmic preparations.
Some of these reactions have resulted in death.
(over)
Clinical and experimental data have demonstrated that corticosteroids
administered orally or by injection to animals may induce the first stage of
parturition if used during the last trimester of pregnancy and may precipitate
premature parturition followed by dystocia, fetal death, retained placenta, and
metritis.
Additionally, corticosteroids administered to dogs, rabbits, and rodents during
pregnancy have resulted in cleft palate in offspring.
Corticosteroids administered to dogs during pregnancy have also resulted in
other congenital anomalies, including deformed forelegs, phocomelia, and anasarca.
PRECAUTIONS: Sensitivity to this ophthalmic ointment is rare, however, if a
reaction occurs, discontinue use of the preparation. The prolonged use of
antibiotic-containing preparations may result in overgrowth of nonsusceptible
organisms including fungi. Appropriate measures should be taken if this occurs.
If infection does not respond to treatment in two or three days, the diagnosis and
therapy should be re-evaluated. Animals under treatment with this product should
be observed for usual signs of corticosteroid overdose which include polydipsia,
polyuria and occasionally an increase in weight.
Use of corticosteroids, depending on dose, duration, and specific steroid, may
result in inhibition of endogenous steroid production following drug withdrawal.
In patients presently receiving or recently withdrawn from systemic
corticosteroid treatments, therapy with a rapidly acting corticosteroid should be
considered in unusually stressful situations. Care should be taken not to
contaminate the applicator tip during the administration of the preparation.
ADVERSE REACTIONS: Itching, burning or inflammation may occur in animals
sensitive to the product. Discontinue use in such cases.
SAP and SGPT (ALT) enzyme elevations, polydipsia and polyuria have occurred
following parenteral or systemic use of synthetic corticosteroids in dogs.
Vomiting and diarrhea (occasionally bloody) have been observed in dogs.
Cushing’s syndrome in dogs has been reported in association with prolonged or
repeated steroid therapy.
For a copy of the Material Safety Data Sheet (MSDS), or to report adverse
reactions, call Dechra Veterinary Products at (866) 933-2472.
DOSAGE AND ADMINISTRATION: Apply a thin film over the cornea three or
four times daily. The area to be treated should be properly cleansed prior to use.
Foreign bodies, crusted exudates and debris should be carefully removed.
Insert the tip of the tube beneath the lower lid and express a small quantity
of the ointment into the conjunctival sac in dogs and cats.
CAUTION: Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
HOW SUPPLIED: 3.5 g (1/8 Oz) sterile tamper proof tubes.
NDC 17033-030-38.
STORE AT 15°-25°C (59°-77°F).
Manufactured for:
Dechra Veterinary Products, Overland Park, KS 66211
033496-00-I Ini0912 R0514